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A Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU (Carmustine) in Patients With Metatstatic Melanoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

Thank you

Trial Information

A Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU (Carmustine) in Patients With Metatstatic Melanoma


OBJECTIVES:

I. Determine the objective clinical response rate and duration of response in patients with
unresectable locally recurrent or metastatic melanoma treated with O6-benzylguanine and
carmustine.

II. Compare the toxicities of this regimen in patients with no prior chemotherapy vs prior
chemotherapy failure.

III. Correlate clinical response to this regimen in these patients with O6-alkylguanine DNA
alkyltransferase (AGT) depletion and baseline AGT in peripheral blood mononuclear cells and
tumor tissue.

OUTLINE: This is a multicenter study. Patients are stratified according to prior
chemotherapy (chemotherapy failure vs chemotherapy naive).

Patients receive O6-benzylguanine IV over 1 hour, followed 1 hour later by carmustine IV
over 1 hour on day 1. Treatment continues every 6 weeks for a minimum of 2 courses in the
absence of disease progression or unacceptable toxicity.

Patients with disease progression are followed every 6 months. All other patients are
followed every 3 months for 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven unresectable locally recurrent or metastatic melanoma

- Chemotherapy naive with no more than 2 prior immunotherapy regimens (including
cytokines, vaccines, or adjuvant interferon) OR

- Prior chemotherapy failure with no more than 2 prior immunotherapy regimens
(including adjuvant interferon) and no more than 1 prior chemotherapy regimen
(which may include carmustine) not including antiangiogenesis therapy

- Measurable disease

- At least 20 mm in at least 1 dimension by conventional technique OR at least 10
mm in at least 1 dimension by spiral CT scan

- No disease confined only to the CNS

- No uncontrolled symptomatic brain metastases regardless of other disease sites

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks

Hematopoietic:

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,200/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- AST and/or ALT no greater than 3 times upper limit of normal

- PT normal

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance greater than 60 mL/min

Pulmonary:

- DLCO at least 70% predicted

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No concurrent significant psychiatric or medical illness, including active
infections, that would interfere with study therapy or increase risk

- No other malignancy within the past 5 years except curatively treated nonmelanomatous
skin cancer, carcinoma in situ of the cervix, or superficial bladder cancer

PRIOR CONCURRENT THERAPY:

Chemotherapy:

- At least 4 weeks since prior systemic chemotherapy (at least 6 weeks since prior
carmustine or mitomycin) and recovered

- No other concurrent chemotherapy or investigational antineoplastic drugs

Radiotherapy:

- At least 2 weeks since prior radiotherapy and recovered

- No concurrent radiotherapy

Surgery:

- At least 3 weeks since prior major surgery and recovered

Other:

- At least 4 weeks since other prior anticancer systemic therapy and recovered

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Thomas F. Gajewski, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02340

NCT ID:

NCT00005961

Start Date:

June 2000

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Ireland Cancer CenterCleveland, Ohio  44106-5065
Loyola University Medical CenterMaywood, Illinois  60153
Lutheran General Cancer Care CenterPark Ridge, Illinois  60068
Evanston Northwestern Health CareEvanston, Illinois  60201
University of Illinois at Chicago Health Sciences CenterChicago, Illinois  60612
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
Fort Wayne Medical Oncology and Hematology, IncorporatedFort Wayne, Indiana  46885-5099
Oncology/Hematology Associates of Central Illinois, P.C.Peoria, Illinois  61602
Central Illinois Hematology Oncology CenterSpringfield, Illinois  62701
Michiana Hematology/Oncology P.C.South Bend, Indiana  46617
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Mercy Ireland Cancer CenterCanton, Ohio  44708